MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number FEM08060

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Material Perforation (2205); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent tip allegedly broken.It was further reported the broken tip was migrated to lung.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 02/2025).

Event Description

It was reported that during a stent placement procedure in cephalic vein, the stent tip allegedly had difficulty in deployment.It was further reported the tip of the delivery system allegedly got entrapped by the stent graft resulting in the detachment of the tip and it was migrated to the lung.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent graft delivery system was returned for evaluation.No x-ray images were provided to verify the reported incomplete expansion as well as the alleged migration of the tip.The stent graft was found deployed and was not returned.The distal end of the stent graft delivery sheath was found damaged; the radiopaque marker band was found detached and missing, and a ripped hole was found in that area.The condition of the delivery system indicates that a strut of the stent graft did perforate the distal end of the stent sheath proximal to the marker band.The target vessel was reported not being torturous.However, no introducer was used during the procedure.Based on evaluation of the device returned and the event information available, the reported difficulties during deployment and the alleged detachment is confirmed.In addition, perforation of the stent sheath caused by stent strut is confirmed.However, the reported migration could not be verified.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding preparation of the device the instructions for use state that 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the instructions for use state: 'prior to stent graft deployment (.), ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible endovascular system failure.' regarding indications for use the instructions for use state 'indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft'.Regarding accessories the instructions for use states: 'prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended.'; the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.H10: d4 (expiry date: 02/2025).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15207814
• MDR Text Key: 299866449
• Report Number: 2020394-2022-00655
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM08060
• Device Catalogue Number: FEM08060
• Device Lot Number: ANGP1658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1